Contact information
Type
Scientific
Primary contact
Dr P W Y de Waard
ORCID ID
Contact details
Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31(0)10 401 7777
deWaard@oogziekenhuis.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OZR-2006-01
Study information
Scientific title
Acronym
Study hypothesis
A single subconjunctival Celestone chronodose injection immediately following cataract extraction reduces the incidence of post-operative ocular inflammation when compared with conventional post-operative eye drops therapy.
Post-op administration of eserine does not reduce the incidence of dislocation of the intraocular lens implant any further.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cataract
Intervention
Group 1: subconjunctival steroid injection.
Group 2: topical steroids (three times per day during three weeks).
Group 3: as group two plus Eserine.
Group 4: as group one plus Eserine.
Intervention type
Drug
Phase
Not Specified
Drug names
Steroids, Celestone chronodose and Eserine
Primary outcome measures
1. Laser flarecount, examined by laser flarecounter, before operation and on day 21.
2. Thickness of the macula, examined by Optical Coherence Tomography (OCT), before operation and on day 21.
Secondary outcome measures
1. Number of extra visits due to complaints of post-op irritation.
2. Number of patients with macular edema, examined by OCT, on day 21.
3. Intraocular pressure on day one and 21.
4. Number of extra visits due to complaints of reduced visual acuity (miotic wearing off).
5. Pain (scaling one to ten) on day one.
6. Incidence of anterior synechiae (gonioscopic evaluation) on day 21.
7. Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart on day 21.
Overall trial start date
01/01/2007
Overall trial end date
30/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Cataract extraction indication
2. Aged over 18 years
3. Caucasian - informed consent
4. Post-op follow-up must be feasible
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
400
Participant exclusion criteria
1. Subcapsular posterior cataract (very soft, short phaco time)
2. Brunescens or mature cataract (hard, long phaco time)
3. Diabetes mellitus
4. Age-related macula degeneration
5. History of uveitis
6. Glaucoma
7. History of steroid response
8. Per-operative iris manipulation (e.g. miosis or posterior synechiae)
9. Pre-operative synechiae anterior
10. Systemic steroid medication
11. Chemotherapy
12. Peroperative contact with vitreous
13. Sickle cell anemia
14. Corneal complications
15. Atopy
16. Herpes Simplex Virus (HSV)
Recruitment start date
01/01/2007
Recruitment end date
30/06/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands
Sponsor information
Organisation
The Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (OZR) (The Netherlands)
Sponsor details
P.O. Box 70030
Rotterdam
3000 LM Rotterdam
Netherlands
+31 (0)10 401 7777
info@oogziekenhuis.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary